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245 00 a| Building a national framework for the establishment of regulatory science for drug developmenth| [electronic resource] :b| workshop summary /c| Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.;

246 30 a| Regulatory science for drug development;

246 30 a| Forum on Drug Discovery, Development, and Translation;

260 a| Washington, D.C. :b| National Academies Press,;

300 a| xvi, 78 p. :b| col. ill. ;c| 23 cm.;

504 a| Includes bibliographical references.;

505 0 a| Introduction -- Defining regulatory sciences -- The urgent need for regulatory science -- Barriers to enhanced regulatory science -- Potential models for building a regulatory science infrastructure -- Challenges in engaging the public policy community -- Envisioning successsful regulatory science at FDA -- Considering next steps.;

506 a| Available only to authorized users.;

520 a| "The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description.;

530 a| Also available online.;

538 a| Mode of access: World Wide Web;

610 10 a| United States.b| Food and Drug Administration.=| ^A1253;

610 12 a| United States.b| Food and Drug Administration.=| ^A1253;

650 0 a| Drug developmentz| United Statesv| Congresses.=| ^A443888;

650 12 a| Drug Discoveryz| United Statesv| Congresses.=| ^A1013013;

650 22 a| Clinical Trials as Topicz| United Statesv| Congresses.=| ^A920927;

650 22 a| Drug Approvalz| United Statesv| Congresses.=| ^A928241;

650 22 a| Drug Evaluationz| United Statesv| Congresses.=| ^A917639;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Lebovitz, Yeonwoo.=| ^A1333491;

700 1 a| English, Rebecca A.=| ^A1108150;

700 1 a| Claiborne, Anne B.=| ^A1108281;

710 2 a| Institute of Medicine (U.S.).b| Forum on Drug Discovery, Development, and Translation.=| ^A1035701;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=3378748;

947 a| (OCoLC)ocn681488332;

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Building a national framework for the establishment of regulatory science for drug development workshop summary / Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Format	Electronic
Publication Info	Washington, D.C. : National Academies Press,
Description	xvi, 78 p. : col. ill. ; 23 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	United States. Food and Drug Administration. United States. Food and Drug Administration. Drug development--United States. --Congresses. Drug Discovery--United States. --Congresses. Clinical Trials as Topic--United States. --Congresses. Drug Approval--United States. --Congresses. Drug Evaluation--United States. --Congresses.

Other author/creator	Lebovitz, Yeonwoo.
Other author/creator	English, Rebecca A.
Other author/creator	Claiborne, Anne B.
Other author/creator	Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation.
Portion of title	Regulatory science for drug development
Portion of title	Forum on Drug Discovery, Development, and Translation
Contents	Introduction -- Defining regulatory sciences -- The urgent need for regulatory science -- Barriers to enhanced regulatory science -- Potential models for building a regulatory science infrastructure -- Challenges in engaging the public policy community -- Envisioning successsful regulatory science at FDA -- Considering next steps.
Abstract	"The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description.
Bibliography note	Includes bibliographical references.
Access restriction	Available only to authorized users.
Other forms	Also available online.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2012472773
ISBN	9780309158893 (pbk.)
ISBN	0309158893 (pbk.)

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